The purpose of this study is to determine whether leaving a thicker layer -which preserves
the tissue called Scarpa's fascia -intact during an abdominoplasty (tummy tuck) decreases
the damage to the lymphatic system.
In order to investigate the effect of leaving a thinner or slightly thicker layer intact
during a tummy tuck, patients who are already planning to undergo the surgery, and who agree
to participate, will be randomly assigned to two groups in a manner similar to flipping a
coin. The first group will have their abdominoplasty performed with a thinner layer of
abdominal wall left in place while the second group will have the surgery with a slightly
thicker layer left in place. Both methods of doing a tummy tuck meet acceptable standards of
care, and the aesthetic outcomes will not be negatively impacted by either of the options.
Before and after the surgery, a procedure called lymphoscintigraphy will be performed.
Lymphoscintigraphy is a special type of imaging where a dye, called a radiotracer, is
injected and then detected by a special camera. The pictures provided by the
lymphoscintigraphy allow investigators to look at the lymphatic system, which is a small
network similar to blood vessels that helps drain extra fluid. The lymphoscintigraphy will
help investigators to know what method of performing the tummy tuck leaves the lymphatic
system most intact.
In addition, photographs of each patient's abdomen will be taken using a special camera that
allows investigators to put the photographs in the computer and compile a 3-dimensional
image. Investigators will be able to look at the volume changes from swelling after the
surgery using these pictures. Finally, an ultrasound will be used to help identify any
seromas, or fluid collections, that may form after the surgery.
The lymphoscintigraphy, photographs and the ultrasound combined will help determine whether
or not leaving a thicker or thinner layer during a tummy tuck helps preserve the fluid
draining lymphatic system and whether or not that effects recovery after the procedure.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The data & information found on this website is provided “AS IS” from ClinicalTrials.gov.
Neither we, the United States Government, U.S. Department of Health and Human Services, National Institutes of Health, National Library of Medicine, nor any of its agencies, contractors, subcontractors or employees of the United States Government make any warranties, expressed or implied, with respect to data found on this site, and, furthermore, assume no liability, or the results of such use, of any part of the data.